Good Manufacturing Practice Audit - GMP Audit

Business Trend

The GMP Audit or Good Manufacturing Practice Audit is an example of a new breed for daily, weekly monthly routines that companies implement to check performance and compliance across critical areas of the business. But these quick audits often fail due to lack of ownership, poorly defined processes and technology – often being no more that Excel checklists with no effective issue or action tracking. The GMP Audit allows companies to track compliance to the guidelines recommended by agencies (such as ISO or FDA standards for example) that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.

Softools Enabler

GMP Audits running on the Softools web application platform are optimised to operate on tablets and smart phones, and so can be conducted by walking around the operations – perhaps as a Gemba Walk. Voice notes can also be taken whilst completing the audit on a tablet or phone to aide the auditor. To avoid the predictability of many audits, individual audit topics or questions can also be pulled out and allocated to auditors or operators at random – thereby embedding a culture of performance and continuous improvement at all levels of the business.

Golden Feature: Highly user friendly design with images and graphics used to make data entry more enjoyable

Actual v. Target results

Set target results for comparison with actual audit results on completion, with colour coded status balls to reflect whether you are on track (green), need further improvement (orange) or in need of urgent action (red).

Interactive visuals

Optimised for use on tablets of handheld devices, audit questions provide an 'should' visual and space for an 'actual' visual where an image can be taken directly there and then by the auditor. Questions are answered by clicking the yes or no button and comments can be captured by dictating or by typing in.

Actions whilst auditing

By integrating the your RAID app with the GMP Audit app you are able to log actions or risks whilst carrying out the audit, assign & notify an owner and set deadlines. By having these apps connected you could have an engineer responding to a risk, before the audit is even completed.